Study To Assess The Pharmacokinetics Of 2 Different Formulations Of PF-04991532

NCT01388829 | Completed Phase 1

• 1 other identifier: B2611015
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to compare the pharmacokinetics of two different lots of tablets.

Conditions

Healthy

Keywords

formulation comparison

Outcome Measures

Primary Outcomes (2)

• Plasma AUClast

  0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours

• Plasma Cmax

  0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours

Secondary Outcomes (1)

• Plasma Tmax

  0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours

Study Arms (1)

formulation comparison

EXPERIMENTAL

formulation comparison

Drug: Treatment A; Drug: Treatment B

Interventions

Treatment A DRUG

150 mg single dose of PF 04991532 tablets (1x150 mg) manufactured from the R3 lot

formulation comparison

Treatment B DRUG

150 mg single dose of PF 04991532 tablets (1x150 mg) manufactured from the R4 lot

formulation comparison

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and/or female (non childbearing potential) subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests. Women must be of non childbearing potential as defined in Lifestyle Guidelines.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
• An informed consent document signed and dated by the subject or a legally acceptable representative.

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
• Screening supine blood pressure 140 mm Hg (systolic) or 90 mm Hg (diastolic), on a single measurement \[confirmed by a single repeat, if necessary\] following at least 5 minutes of rest.
• Any condition possibly affecting drug absorption (eg, gastrectomy).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: July 7, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 10, 2011

Record last verified: 2011-08

Locations

US (1)